Ischemic Stroke Clinical Trial
— MaRISSOfficial title:
Mild and Rapidly Improving Stroke Study
| NCT number | NCT02072681 |
| Other study ID # | 20120079 |
| Secondary ID | |
| Status | Completed |
| Phase | |
| First received | |
| Last updated | |
| Start date | March 2015 |
| Est. completion date | June 30, 2021 |
| Verified date | July 2021 |
| Source | University of Miami |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational [Patient Registry] |
The objective of this study is to determine the 90-day outcomes of mild and rapidly improving ischemic stroke.
| Status | Completed |
| Enrollment | 2175 |
| Est. completion date | June 30, 2021 |
| Est. primary completion date | December 31, 2020 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | Inclusion Criteria: - Mild or spontaneously rapidly improving ischemic stroke confirmed by neuroimaging - Arrival to hospital within 4.5 hours of symptom onset - Willing to provide consent - Available for a telephone interview at 30 and 90 days Exclusion Criteria: - Onset >4.5 hours - Unable to provide informed consent (patient or legally appointed representative - Premorbid modified Rankin Scale >1 - Unavailable by telephone for follow-up |
| Country | Name | City | State |
|---|---|---|---|
| United States | Saint Peter's Hospital | Albany | New York |
| United States | UPMC Altoona | Altoona | Pennsylvania |
| United States | Alexian Brothers | Arlington Heights | Illinois |
| United States | King's Daughters Medical Center | Ashland | Kentucky |
| United States | Seton Medical Center | Austin | Texas |
| United States | Seton Medical Center-Brackenridge | Austin | Texas |
| United States | St. David's Medical Center/Neuro Texas Institute | Austin | Texas |
| United States | Eastern Maine Medical Center | Bangor | Maine |
| United States | Overlake Hospital Medical Center | Bellevue | Washington |
| United States | Boston Medical Center | Boston | Massachusetts |
| United States | Ocean Medical Center | Brick | New Jersey |
| United States | Albert Einstein College of Medicine-Montefiore Medical Center | Bronx | New York |
| United States | New York Methodist Hospital | Brooklyn | New York |
| United States | SUNY Downstate Medical Center | Brooklyn | New York |
| United States | Mercy Hospital of Buffalo | Buffalo | New York |
| United States | University of Vermont | Burlington | Vermont |
| United States | Chandler Regional Medical Center | Chandler | Arizona |
| United States | Carolinas HealthCare System | Charlotte | North Carolina |
| United States | University of Cincinnati Medical Center | Cincinnati | Ohio |
| United States | Kaiser Permanente Northwest Sunnyside Medical Center | Clackamas | Oregon |
| United States | MetroHealth Medical Center | Cleveland | Ohio |
| United States | Memorial Hospital Central | Colorado Springs | Colorado |
| United States | Ohio State University Wexner Medical Center | Columbus | Ohio |
| United States | Ascencion-St. John Providence | Detroit | Michigan |
| United States | Henry Ford Health System | Detroit | Michigan |
| United States | Saint Vincent Hospital | Erie | Pennsylvania |
| United States | UPMC Hamot | Erie | Pennsylvania |
| United States | Lutheran Hospital | Fort Wayne | Indiana |
| United States | Parkview Research Center | Fort Wayne | Indiana |
| United States | JPS Health Network | Fort Worth | Texas |
| United States | Shands Hospital- University of Florida | Gainesville | Florida |
| United States | Methodist Hospitals | Gary | Indiana |
| United States | Spectrum Health | Grand Rapids | Michigan |
| United States | Greenville Memorial Hospital | Greenville | South Carolina |
| United States | Pennsylvania State University / The Milton S. Hershey Medical Center | Hershey | Pennsylvania |
| United States | The Queen's Medical Center | Honolulu | Hawaii |
| United States | Houston Methodist Hospital | Houston | Texas |
| United States | St. Vincent Hospital Indianapolis | Indianapolis | Indiana |
| United States | Mississippi Baptist Medical Center | Jackson | Mississippi |
| United States | University of Mississippi Medical Center | Jackson | Mississippi |
| United States | Conemaugh Memorial Medical Center | Johnstown | Pennsylvania |
| United States | Ascension-Borgess | Kalamazoo | Michigan |
| United States | St. Luke's Neuroscience Institute | Kansas City | Missouri |
| United States | Osceola Regional Medical Center | Kissimmee | Florida |
| United States | Baptist Health Lexington | Lexington | Kentucky |
| United States | Long Beach Memorial Medical Center | Long Beach | California |
| United States | Good Samaritan Hospital | Los Angeles | California |
| United States | Kaiser Permanente South California | Los Angeles | California |
| United States | Norton HealthCare | Louisville | Kentucky |
| United States | University of Louisville | Louisville | Kentucky |
| United States | Medical Center, Navicent Health | Macon | Georgia |
| United States | WellStar Health System-Kennestone Hospital | Marietta | Georgia |
| United States | Jackson Memorial Hospital | Miami | Florida |
| United States | Aurora BayCare Medical Center | Milwaukee | Wisconsin |
| United States | Aurora Medical Center Grafton | Milwaukee | Wisconsin |
| United States | Aurora St. Luke's Medical Center | Milwaukee | Wisconsin |
| United States | Providence Holy Cross Medical Center | Mission Hills | California |
| United States | Riverside University Health System Medical Center | Moreno Valley | California |
| United States | Carolina Healthcare Blue Ridge | Morganton | North Carolina |
| United States | West Virginia University | Morgantown | West Virginia |
| United States | Intermountain Medical Center Neuroscience Institute | Murray | Utah |
| United States | Hackensack Meridian Health/Jersey Shore University Medical Center | Neptune | New Jersey |
| United States | The Hospital of Central Connecticut | New Britain | Connecticut |
| United States | Ochsner Medical Center | New Orleans | Louisiana |
| United States | Bon Secours Hampton Roads | Norfolk | Virginia |
| United States | INTEGRIS Baptist Medical Center | Oklahoma City | Oklahoma |
| United States | Mercy Hospital | Oklahoma City | Oklahoma |
| United States | Florida Hospital | Orlando | Florida |
| United States | Southern California Permanente Medical Group / Downey | Pasadena | California |
| United States | St. Joseph's Regional Medical Center | Paterson | New Jersey |
| United States | Sacred Heart Hospital | Pensacola | Florida |
| United States | Berkshire Medical Center | Pittsfield | Massachusetts |
| United States | Pomona Valley Hospital Medical Center | Pomona | California |
| United States | Legacy Emanuel Medical Center | Portland | Oregon |
| United States | Providence St. Vincent | Portland | Oregon |
| United States | Rhode Island Hospital | Providence | Rhode Island |
| United States | The Valley Hospital | Ridgewood | New Jersey |
| United States | Rochester General Hospital | Rochester | New York |
| United States | Univ of Rochester - Strong Memorial Hospital | Rochester | New York |
| United States | Kaiser Permanente Northern California (Sacramento) | Sacramento | California |
| United States | Mercy Hospital St. Louis | Saint Louis | Missouri |
| United States | SSM Health Care St. Louis | Saint Louis | Missouri |
| United States | St. Anthony's Medical Center | Saint Louis | Missouri |
| United States | Orange County Global Medical Center | Santa Ana | California |
| United States | HonorHealth | Scottsdale | Arizona |
| United States | Cox Medical Centers | Springfield | Missouri |
| United States | Memorial Medical Center | Springfield | Illinois |
| United States | Crouse Hospital | Syracuse | New York |
| United States | Morton Plant Mease Healthcare | Tampa | Florida |
| United States | Scott & White Memorial Hospital | Temple | Texas |
| United States | Saint Francis Hospital | Tulsa | Oklahoma |
| United States | Faxton St. Luke's Healthcare | Utica | New York |
| United States | Clear Lake Regional Medical Center | Webster | Texas |
| United States | Wesley Medical Center | Wichita | Kansas |
| United States | Central DuPage Hospital Association | Winfield | Illinois |
| United States | Novant Forsyth Medical Center | Winston-Salem | North Carolina |
| United States | Wake Forest University Health Sciences | Winston-Salem | North Carolina |
| Lead Sponsor | Collaborator |
|---|---|
| University of Miami | American Heart Association, Genentech, Inc. |
United States,
Romano JG, Gardener H, Campo-Bustillo I, Khan Y, Riley N, Tai S, Sacco RL, Khatri P, Smith EE, Schwamm LH. The Mild and Rapidly Improving Stroke Study (MaRISS): Rationale and design. Int J Stroke. 2019 Dec;14(9):983-986. doi: 10.1177/1747493019873595. Epub 2019 Sep 7. — View Citation
Romano JG, Gardener H, Campo-Bustillo I, Khan Y, Tai S, Riley N, Smith EE, Sacco RL, Khatri P, Alger HM, Mac Grory B, Gulati D, Sangha NS, Craig JM, Olds KE, Benesch CG, Kelly AG, Brehaut SS, Kansara AC, Schwamm LH; MaRISS Investigators*. Predictors of Ou — View Citation
Romano JG, Smith EE, Liang L, Gardener H, Camp S, Shuey L, Cook A, Campo-Bustillo I, Khatri P, Bhatt DL, Fonarow GC, Sacco RL, Schwamm LH. Outcomes in mild acute ischemic stroke treated with intravenous thrombolysis: a retrospective analysis of the Get With the Guidelines-Stroke registry. JAMA Neurol. 2015 Apr;72(4):423-31. doi: 10.1001/jamaneurol.2014.4354. — View Citation
Romano JG, Smith EE, Liang L, Gardener H, Campo-Bustillo I, Khatri P, Bhatt DL, Fonarow GC, Sacco RL, Schwamm LH. Distinct Short-Term Outcomes in Patients With Mild Versus Rapidly Improving Stroke Not Treated With Thrombolytics. Stroke. 2016 May;47(5):1278-85. doi: 10.1161/STROKEAHA.115.011528. Epub 2016 Mar 17. — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Proportion of patients not independent at 90 days | The primary outcome measure is proportion of patients with a modified Rankin Scale of 2-6 at 90 days | 90 days | |
| Secondary | Proportion of patients with dependence or disability in activities of daily living at 90 days | Proportion of patients not independent in activities of daily living defined as a Barthel Index score <95 | 90 days | |
| Secondary | Symptomatic intracranial hemorrhage due to Alteplase | Amongst those that receive intravenous Alteplase, a secondary safety measure is the proportion of patients that develop neurologic worsening development of symptomatic intracerebral hemorrhage, defined as neurological deterioration that, in the judgment of the investigator, is related to intracranial hemorrhage confirmed by CT or MRI, within 36 hours of administration of Alteplase. | 36 hours | |
| Secondary | Proportion of patients not independent at 30 days | Proportion of patients with modified Rankin Scale 2-6 at 30 days. | 30 days | |
| Secondary | Quality of life by the EuroQOL EQ-5D | EuroQOL will be treated as a continuous measure | 90 days | |
| Secondary | Stroke disability by the Stroke-Impact Scale-16 | SIS-16 will be treated as a continuous measure | 90 days | |
| Secondary | Independence with Activities of Daily Living by the Barthel Index | BI will be treated as a continuous measure; pre specified analysis include proportion of patients with Barthel Index <95 | 90 days |
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT05196659 -
Collaborative Quality Improvement (C-QIP) Study
|
N/A | |
| Recruiting |
NCT06027788 -
CTSN Embolic Protection Trial
|
N/A | |
| Completed |
NCT03281590 -
Stroke and Cerebrovascular Diseases Registry
|
||
| Recruiting |
NCT05518305 -
Platelet Expression of FcγRIIa and Arterial Hemodynamics to Predict Recurrent Stroke in Intracranial Atherosclerosis
|
||
| Recruiting |
NCT06029959 -
Stroke and CPAP Outcome Study 3
|
N/A | |
| Recruiting |
NCT03728738 -
Zero Degree Head Positioning in Hyperacute Large Artery Ischemic Stroke
|
Phase 3 | |
| Terminated |
NCT03396419 -
IMPACT- 24col Collateral Blood Flow Assessment Following SPG Stimulation in Acute Ischemic Stroke (ImpACT-24B Sub-Study)
|
||
| Recruiting |
NCT05065216 -
Treatment of Acute Ischemic Stroke (ReMEDy2 Trial)
|
Phase 2/Phase 3 | |
| Recruiting |
NCT04897334 -
Transcranial Direct Current Stimulation and Rehabilitation to Ameliorate Impairments in Neurocognition After Stroke
|
N/A | |
| Not yet recruiting |
NCT06462599 -
Osteopontin Gene Polymorphism in Stroke Patients in Egypt
|
||
| Not yet recruiting |
NCT06026696 -
Cohort of Neurovascular Diseases Treated in the Acute Phase and Followed at Lariboisière
|
||
| Not yet recruiting |
NCT06032819 -
Differentiating Between Brain Hemorrhage and Contrast
|
||
| Recruiting |
NCT02910180 -
Genetic, Metabolic, and Growth Factor Repository for Cerebrovascular Disorders
|
||
| Withdrawn |
NCT01866189 -
Identification of Hypoxic Brain Tissues by F-MISO PET in Acute Ischemic Stroke
|
N/A | |
| Completed |
NCT02922452 -
A Study to Evaluate the Effect of Diltiazem on the Pharmacokinetics (PK) of BMS-986141 in Healthy Subjects
|
Phase 1 | |
| Completed |
NCT03554642 -
Walkbot Robotic Training for Improvement in Gait
|
Phase 3 | |
| Recruiting |
NCT03041753 -
Reperfusion Injury After Stroke Study
|
N/A | |
| Completed |
NCT02549846 -
AdminiStration of Statin On Acute Ischemic stRoke patienT Trial
|
Phase 4 | |
| Completed |
NCT01678534 -
Reparative Therapy in Acute Ischemic Stroke With Allogenic Mesenchymal Stem Cells From Adipose Tissue, Safety Assessment, a Randomised, Double Blind Placebo Controlled Single Center Pilot Clinical Trial
|
Phase 2 | |
| Completed |
NCT02610803 -
Paroxysmal Atrial Fibrillation in Patients With Acute Ischemic Stroke
|
N/A |